Regulatory Affairs Specialist (NMPA)

Regulatory Affairs Specialist (NMPA)

This position will partner with the in-country RA team as well as the Product Localization Engineering (PLE) and other cross-functional supporting teams, make sure the company's regulatory affairs activities are conducted in accordance with company policies and in compliance with the latest relevant regulations and standards, so that regulatory compliance against China requirement is ensured for all relevant aspects throughout the lifecycle of the products subject to China market. Additional responsibilities include maintaining regulatory filings and licenses. Provide support to cross-functional team, responsible for the assigned tasks pertaining to pre-market applications and/or post-market regulatory compliances.

Essential Job Duties

• Act as the RA project lead when support China product registration applications. Such role covers the responsibilities of being both 'the RA Lead at ISI side' and 'the RA Project Manager', more specific speaking, responsible for the followings:
• Coordinate and assist in efforts of regulatory/clinical strategy development and timeline establishment.
• With the collaboration with JVRA, provide explanation to ISI supportive teams on China regulatory requirement to ensure the deliverables prepared for NMPA submission are compliant.
• Coordinate and prioritize tasks assigned with oversight.
• Support the activities pertaining to the Product Technical Requirement (PTR) draft and type testing, including test sample arrangement.
• Responsible for the writing, review of certain sections of the dossier.
• Coordinate and work with JVRA and ISI stakeholders on providing supportive information that are required for regulator communications (consultation, workshop, etc.).
• Create and maintain the registration tracker to ensure the deliverables required for submission or deficiency response are comprehensively captured covering all relevant aspects and updated timely when progress is made.
• Maintain the China Regulatory Project Executive Summary for responsible projects.
• As a member of the China/HK RAQA group, is required to demonstrate flexibility as priorities change.
• Support department goals and continuous improvement initiatives.
• Review and approve GRAs
• Articulate local regulatory requirements to the organization as needed; Assist in developing or revising internal procedures to ensure continuous compliance with all China applicable regulatory requirements.
• Support (in back room) in internal and external audits related to China compliance.
• Provide support in China localization projects when needed (manufacturing transfer, etc)
• Work with post-market team in support of the China Periodic Safety Update Reports (PSUR) generation.
• Provide working-level guidance to contractor for completing the task assigned.

Qualifications

Required Skills and Experience

• Hybrid onsite weekly in Sunnyvale, CA or Peachtree Corners, GA
• Mandarin Chinese speaking is required for this position
• Minimum 3 years RA experience is required.
• Minimum 1 year of NMPA medical device regulatory requirement China GB/YY standards, as well as fundamental US FDA requirements posed on medical device.
• Experience with new product development projects for complex products.
• Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions.
• Good interpersonal skills and able to work well with cross- functional teams.
• Solid project management skills, experience of working (as a leader or co-leader or project manager) cross-functionally/regionally to support strategy development, drive planning and execution of ambitious goals.
• Keen on delivering quality results and introducing best practices.
• Highly proficient in Microsoft Word, Excel, and Project applications

Required Education and Training

• Education: B.S./B.E. or higher in life science, biomedical engineering or related filed.
• Advanced degree preferred.

Preferred Skills and Experience

• SaMD and SiMD knowledge a plus.
• Experience with RIMS (e.g., Veeva, Rimsys, etc.) is a plus.
• RAC (regulatory affairs certified) desirable.
• Knowledge of SAP, Agile or similar business systems is desired.